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Abstract Details

Five-by-Five: Nationwide Real-world Outcomes after =Five Years of Cladribine With an Age =50 Subanalysis
Multiple Sclerosis
P2 - Poster Session 2 (11:45 AM-12:45 PM)
20-006
To assess long-term use of cladribine in people with multiple sclerosis (pwMS), including retreatment efficacy and observations in pwMS aged ≥50 years at baseline (first cladribine tablet) in real-world settings.

While cladribine shows sustained efficacy through 4 years in trials, real-world evidence beyond this timepoint remains limited, particularly retreatment strategies and age-specific outcomes.

We used data from the Czech national MS registry (ReMuS) and included pwMS who had completed full 2 courses of cladribine by June 30, 2025, with ≥5 years of follow-up. We assessed clinical effectiveness and treatment patterns. Patients were classified as: N (no further treatment), R (retreatment with cladribine), and S (switch to another therapy). We performed exploratory analysis in pwMS aged ≥50.

Of 1,749 pwMS completing 2 cladribine courses, 352 had ≥5-year follow-up (mean ±SD baseline age 37.1±9.3 years, 74% female, 92% pre-treated [14% high-efficacy disease-modifying therapies], EDSS 2.7±1.2). At year 5, 41% remained relapse-free, 89% PIRA-free, and 71% 3-month CDP-free. Groups N/R/S comprised 50.6%/26.1%/23.3% of pwMS, with majority of retreatments occurring in year 5. Among 79 retreated patients with ≥1-year follow-up after retreatment, relapse-free rates increased from 38% in a year pre-retreatment to 85% in a year post-retreatment. In the age ≥50 subgroup (n=33), 67% required no further treatment (vs 49% in <50), only 9.1% switched (vs 25% in <50), and all retreated patients achieved relapse-free status, with other disease characteristics comparable to pwMS aged <50 years.

More than half of pwMS do not require additional treatment 5 years after initiating cladribine tablets, despite not being treatment-naïve. Retreatment appears to be a beneficial strategy, effectively restoring disease control with relapse-free rates increasing from 38% to 85%. PwMS aged ≥50 years showed encouraging patterns consistent with suitability for an exit-strategy subgroup, albeit with interpretation limited by small sample size.

Authors/Disclosures
Dominika Stastna, MD, PhD (General University Hospital in Prague)
PRESENTER
Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Stastna has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Stastna has received publishing royalties from a publication relating to health care.
Marta Vachova, MD Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Vachova has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Jiri Drahota, MSc (ReMuS Registry) Jiri Drahota has received personal compensation for serving as an employee of IMPULS Endowment Fund. Jiri Drahota has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche s.r.o.. Jiri Drahota has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis s.r.o..
Pavel Potuznik Pavel Potuznik has nothing to disclose.
Radek Ampapa, MD (Neurologicka Klinika Jihlava) Dr. Ampapa has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Dr. Ampapa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzym. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Ampapa has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Michal Dufek, PhD Dr. Dufek has nothing to disclose.
Marketa Grunermelova Dr. Grunermelova has nothing to disclose.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK) Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Jana Houskova, MD Mrs. Houskova has nothing to disclose.
Jana Libertinova (Bristol Myers Squibb) Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Merck Serono. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Roche. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Bristol Mayer Squibb. Ms. Libertinova has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva.
Alena Martinkova, MD Dr. Martinkova has nothing to disclose.
Zbyšek Pavelek, MD Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for bristol myers squibb. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Pavelek has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva.
Marek Peterka Marek Peterka has nothing to disclose.
Eva Recmanova, MD (Nemocnice Zlin) Dr. Recmanova has nothing to disclose.
Zuzana Rous, PhD Dr. Rous has nothing to disclose.
Matous Rous, MD Dr. Rous has nothing to disclose.
Ivana Stetkarova, MD, PhD (Charles University, Third Faculty of Medicine, Department of University) Ivana Stetkarova, MD, PhD has nothing to disclose.
Pavel Stourac, MD (University Hospital Brno, Neurology Clinic) Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol- Myers Squibb. Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Stourac has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Novartis .
Ivana Woznicova, MD Dr. Woznicova has nothing to disclose.
Dana Horakova Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dana Horakova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Gregor Fistravec, Other (Registr ReMuS) Mr. Fistravec has received personal compensation for serving as an employee of IMPULS , nadacní fond.